The effectiveness of daclatasvir based therapy in European patients with chronic hepatitis C and advanced liver disease

Fecha de publicación: 07/01/2017

Autores de IIS La Fe

Martín Prieto Castillo

Autor

Participantes ajenos a IIS La Fe

Young, J
Weis, N
Hofer, H
Irving, W
Weiland, O
Giostra, E
Pascasio, JM
Castells, L
Postema, R
Lefevre, C
Evans, D
Bucher, HC
Calleja, JL

Grupos

Hepatología experimental y Trasplante hepático

Investigador Principal

Laia Tolosa Pardo

Abstract

Background: There is limited evidence for the effectiveness of daclatasvir in patients whose hepatitis C threatens their life expectancy. The Named Patient Program in Europe included patients with advanced chronic hepatitis C, a life expectancy of less than 12 months and no other treatment options. Methods: A retrospective multi-country cohort of patients with chronic hepatitis C who received daclatasvir as part of the Named Patient Program in Austria, Denmark, Spain, Sweden, Switzerland and the United Kingdom. Treatment response was defined as a sustained virologic response (unquantifiable hepatitis C RNA) at 12 weeks post treatment. We summarised the characteristics of the patients in this cohort and estimated the rate of sustained virologic response for patients receiving daclatasvir and sofosbuvir with or without ribavirin using hierarchical Bayesian modelling. Results: The 249 patients included had a median age of 56 years; most were male (78%), hepatitis C genotype 1 (75%), treatment experienced (65%) and with decompensated cirrhosis (59%). Many had had a liver transplant before receiving daclatasvir (40%). Of the 249 patients, 242 patients received daclatasvir and sofosbuvir and either reached 12 weeks post treatment or died during (n = 9) or after treatment (n = 4) or were lost to follow up during treatment (n = 1). The estimated rate of sustained virologic response at 12 weeks post treatment was 87% (95% credible interval 75 to 94%) for previously treated genotype 1 patients with decompensated cirrhosis. Conclusions: Daclatasvir with sofosbuvir is an effective treatment in clinical practice for hepatitis C genotype 1 patients with decompensated cirrhosis.

Datos de la publicación

ISSN/ISSNe:: 1471-2334, 1471-2334
Tipo:: Article
Páginas:: 45-45
DOI:: 10.1186/s12879-016-2106-x
Factor de Impacto:: 1,576 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Métricas

Filiaciones

Young, J:: Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, CH-4031, Basel, Switzerland.

Univ Basel Hosp, Basel Inst Clin Epidemiol & Biostat, Spitalstr 12, CH-4031 Basel, Switzerland
Weis, N:: Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark

Copenhagen Univ Hosp, Dept Infect Dis, Hvidovre, Denmark
Hofer, H:: Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria

Med Univ Vienna, Div Gastroenterol & Hepatol, Dept Internal Med 3, Vienna, Austria
Irving, W:: NIHR Nottingham Digestive Diseases Biomedical Research Unit, University of Nottingham, Nottingham, UK

Univ Nottingham, NIHR Nottingham Digest Dis Biomed Res Unit, Nottingham, England
Weiland, O:: Division of Infectious Diseases, Department of Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden

Karolinska Univ, Karolinska Inst, Div Infect Dis, Hosp Huddinge,Dept Med, Stockholm, Sweden
Giostra, E:: Service de Gastroentérologie et Hépatologie, Hôpitaux universitaires de Genève, Geneva, Switzerland

Hop Univ Geneva, Serv Gastroenterol & Hepatol, Geneva, Switzerland
Pascasio, JM:: Hospital Universitario Virgen del Rocío, Seville, Spain

Hosp Univ Virgen del Rocio, Seville, Spain
Castells, L:: Liver Unit, Internal Medicine Department, Hospital Universitari Vall Hebron, Barcelona, Spain

Hosp Univ Vall Hebron, Dept Internal Med, Liver Unit, Barcelona, Spain
Prieto, M:: Hepatology Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain

Hosp Univ & Politecn La Fe, Hepatol Unit, Valencia, Spain
Postema, R:: Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Uxbridge, United Kingdom

Bristol Myers Squibb, Worldwide Hlth Econ & Outcomes Res, Uxbridge, Middx, England
Lefevre, C:: Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Rueil-Malmaison, France

Bristol Myers Squibb, Worldwide Hlth Econ & Outcomes Res, Rueil Malmaison, France
Evans, D:: Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Rueil-Malmaison, France

Bristol Myers Squibb, Worldwide Hlth Econ & Outcomes Res, Rueil Malmaison, France
Bucher, HC:: Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, CH-4031, Basel, Switzerland

Univ Basel Hosp, Basel Inst Clin Epidemiol & Biostat, Spitalstr 12, CH-4031 Basel, Switzerland
Calleja, JL:: Liver Unit, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, Madrid, Spain

Univ Autonoma Madrid, Hosp Univ Puerta Hierro, Liver Unit, Madrid, Spain